A5112538911- HER2/EGFR in Cancer Research
- Gastric Cancer Management and Outcomes
- Monoclonal and Polyclonal Antibodies Research
- Intracranial Aneurysms: Treatment and Complications
- Cerebrovascular and Carotid Artery Diseases
- Lung Cancer Treatments and Mutations
- Cancer Treatment and Pharmacology
- Acute Ischemic Stroke Management
- Advanced Breast Cancer Therapies
- Peptidase Inhibition and Analysis
- Cancer therapeutics and mechanisms
- Gastrointestinal Tumor Research and Treatment
- Neutropenia and Cancer Infections
- Lung Cancer Research Studies
- Health Systems, Economic Evaluations, Quality of Life
- Colorectal Cancer Treatments and Studies
- Statistical Methods in Clinical Trials
- Advanced Causal Inference Techniques
- Lipoproteins and Cardiovascular Health
- Advanced Glycation End Products research
- Hepatocellular Carcinoma Treatment and Prognosis
- Liver Disease Diagnosis and Treatment
- Pharmacovigilance and Adverse Drug Reactions
- Botulinum Toxin and Related Neurological Disorders
- Cancer, Lipids, and Metabolism
Daiichi-Sankyo (Japan)
2015-2024
Kanagawa Cancer Center
2023
Kanagawa Prefectural Hospital Organization
2023
Hyogo Brain and Heart Center
2011-2021
Fukuyama City Hospital
2021
Daiichi Sankyo (Germany)
2009-2020
Daiichi-Sankyo (South Korea)
2020
Memorial Sloan Kettering Cancer Center
2020
Aichi Cancer Center
2020
National Cancer Center
2020
Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate consisting of anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and cytotoxic topoisomerase I inhibitor. The drug may have efficacy in patients with HER2-positive advanced gastric cancer.In open-label, randomized, phase 2 trial, we evaluated trastuzumab as compared chemotherapy cancer. Patients centrally confirmed or gastroesophageal junction adenocarcinoma that had progressed...
Trastuzumab deruxtecan (T-DXd, formerly DS-8201a) is a novel human epidermal growth factor receptor 2 (HER2)-targeted antibody drug conjugate (ADC) with topoisomerase I inhibitor payload. A dose escalation and expansion phase study evaluated the safety activity of T-DXd in patients advanced HER2-expressing/mutated solid tumors. Here, results for at recommended doses (RDE) HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in situ hybridization-) breast cancer (ClinicalTrials.gov identifier:...
HER2-targeted therapies are approved only for HER2-positive breast and gastric cancers. We assessed the safety/tolerability activity of novel antibody-drug conjugate trastuzumab deruxtecan (T-DXd) in 60 patients with pretreated, HER2-expressing (IHC ≥ 1+), non-breast/non-gastric or HER2-mutant solid tumors from a phase I trial (NCT02564900). Most common (>50%) treatment-emergent adverse events (TEAE) were nausea, decreased appetite, vomiting. Two drug-related TEAEs associated fatal outcomes....
To investigate efficacy and safety of trastuzumab deruxtecan (T-DXd) in human epidermal growth factor receptor 2 (HER2)-low gastric or gastroesophageal junction (GEJ) adenocarcinoma.Patients with locally advanced metastatic HER2-low (cohort 1, immunohistochemistry 2+/in situ hybridization-negative; cohort 2, 1+) gastric/GEJ adenocarcinoma treated at least two prior regimens, including fluoropyrimidine platinum, but anti-HER2 therapy naive, received T-DXd 6.4 mg/kg intravenously once every 3...
2501 Background: DS-8201a is a HER2-targeted antibody drug conjugate with novel topoisomerase I inhibitor payload and linker technology. Methods: This ongoing phase 1 study (NCT02564900) enrolls subjects (sbj) HER2+ breast cancer (BC) post T-DM1, gastric (GC) trastuzumab, HER2 low BC (IHC 1+ or 2+, ISH-), other HER2-expressing solid tumors ≥1+). Results: [Results will be updated for presentation at meeting] From Sep 2015–Dec 2017, 212 sbj received ≥1 dose of DS-8201a; 200 5.4 6.4 mg/kg....
Abstract This study investigated the safety and efficacy of mirogabalin, a novel, potent, selective ligand α 2 δ subunit voltage-dependent Ca 2+ channels, for treatment postherpetic neuralgia (PHN). In this multicenter, double-blind, placebo-controlled phase 3 study, Asian patients ≥20 years with PHN were randomized 2:1:1:1 to placebo or mirogabalin 15, 20, 30 mg/day up 14 weeks (NCT02318719). The primary endpoint was change from baseline in average daily pain score at week 14, defined as...
Abstract Background HER2-expressing salivary gland carcinoma (SGC) is associated with poor prognosis. Trastuzumab deruxtecan (T-DXd, DS-8201) has shown evidence of antitumor activity for several solid tumors in multiple studies. This study aimed to present the efficacy and safety T-DXd patients SGC from a pooled analysis. Methods Patients were two phase I, open-label studies T-DXd: two-phase, multiple-dose, first-in-human (NCT02564900) single-sequence crossover drug–drug interaction...
Summary Background Pexidartinib, a novel, orally administered small-molecule tyrosine kinase inhibitor, has strong selectivity against colony-stimulating factor 1 receptor. This phase I, nonrandomized, open-label multiple-dose study evaluated pexidartinib safety and efficacy in Asian patients with symptomatic, advanced solid tumors. Materials Methods Patients received pexidartinib: cohort 1, 600 mg/d; 2, 1000 mg/d for 2 weeks, then 800 mg/d. Primary objectives assessed tolerability,...
Abstract The global phase 3 DESTINY‐Breast03 study ( ClinicalTrials.gov ; NCT03529110) showed statistically significant and clinically meaningful improvements in progression‐free survival (PFS) overall (OS) with trastuzumab deruxtecan (T‐DXd) over emtansine (T‐DM1) patients human epidermal growth factor receptor 2 (HER2)‐positive metastatic breast cancer (mBC) previously treated a taxane. Here, we report subgroup analysis of Asian enrolled DESTINY‐Breast03. In total, 309 (149 the T‐DXd arm...
Abstract In survival analysis, treatment effects are commonly evaluated based on curves and hazard ratios as causal effects. observational studies, these estimates may be biased due to confounding factors. The inverse probability of weighted (IPTW) method the propensity score is one approaches utilized adjust for factors between binary groups. As a generalization this methodology, we developed an exact formula IPTW log‐rank test generalized data. This makes it possible compare group...
Abstract Background In the global phase 3 DESTINY-Breast04 study (NCT03734029), anti-human epidermal growth factor 2 (HER2) antibody–drug conjugate trastuzumab deruxtecan (T-DXd) demonstrated a statistically significant improvement in progression-free survival (PFS) and overall (OS), with manageable safety compared treatment of physician’s choice (TPC) patients HER2-low metastatic breast cancer (mBC) who had received 1–2 prior lines chemotherapy. Methods This subgroup analysis examined...
6079 Background: T-DXd is an antibody-drug conjugate composed of anti-HER2 antibody, cleavable tetrapeptide-based linker, and membrane-permeable topoisomerase I inhibitor payload. has been approved for use in the US Japan both breast cancer gastric demonstrated safety efficacy additional solid tumors indications first-in-human (FIH) (J101; NCT02564900) drug-drug interaction (DDI) (A104; NCT03383692) phase 1 studies. Here we present combined subgroup analysis salivary duct carcinoma. Methods:...
2512 Background: U3-1402 is a human epidermal growth factor receptor 3 (HER3)-targeting antibody-drug conjugate (ADC) of high drug-to-antibody-ratio (DAR: 7 to 8) with novel linker and topoisomerase I inhibitor payload. HER3 overexpressed in variety cancers, including breast, lung, colorectal, ovarian, prostate urothelial cancer. This ongoing, Phase 1/2 study (NCT02980341) HER3-expressing metastatic breast cancer (MBC) divided into three parts: dose escalation (Part 1), finding 2), expansion...
Abstract Mirogabalin (DS‐5565) is a novel preferentially selective α 2 δ‐1 ligand being developed for the treatment of diabetic peripheral neuropathic pain and postherpetic neuralgia. The current multicenter open‐label study determined effect varying degrees renal impairment on pharmacokinetics safety single dose mirogabalin 5 mg in Japanese subjects. A total 30 subjects (6 per function category [normal, mild, moderate, or severe impairment; end‐stage disease (ESRD)]) were enrolled completed...
Aim Irinotecan-induced severe toxicities are possibly related to UGT1A1*6 and *28 genotypes. However, the correlation between UGT1A1 polymorphisms risk of induced by low-dose irinotecan plus platinum combination therapy still remains controversial. This prospective observational study aimed examine genotypes clinical outcomes (median 60 mg/m2, range 25–115 mg/m2) in Japanese patients with solid tumors. Methods Toxicity profiles were compared SNP heterozygotes (hetero-group) homozygous...
242 Background: T-DXd is an antibody-drug conjugate comprising anti-HER2 antibody, a cleavable tetrapeptide-based linker, and topoisomerase I inhibitor. DESTINY-Gastric01 (DS8201-A-J202; ClinicalTrials.gov, NCT03329690) open-label, multicenter, randomized, phase 2 trial of in patients with HER2–positive advanced gastric cancer (GC) or GEJ adenocarcinoma. In the primary analysis (101 OS events; median survival follow-up, 12.3 mo), showed statistically significant benefit vs standard...
This study aimed to evaluate the relationship between low-density lipoprotein cholesterol (LDL-C) levels and cardiovascular disease (CVD) in high-risk patients with hypercholesterolemia without a history of CVD. Patients who were receiving or started treatment pravastatin, followed-up for 2 years. divided into quartiles according on-treatment LDL-C. The maximum contrast method based on Cox proportional hazards model was used achieved LDL-C incidence Incidence CVD also compared whether number...
4048 Background: T-DXd is an antibody–drug conjugate comprising anti-HER2 antibody, a cleavable tetrapeptide-based linker, and topoisomerase I inhibitor. DESTINY-Gastric01 (DS8201-A-J202; ClinicalTrials.gov, NCT03329690) open-label, multicenter, randomized, phase 2 trial of in patients with HER2-positive advanced gastric cancer (GC) or GEJ adenocarcinoma. In the primary analysis (101 OS events; median survival follow-up, 12.3 mo), showed statistically significant benefit vs standard...